FDA Announces Two New AofC Codes for Kits of Medical Devices
U.S. Customs and Border Protection has issued a CSMS message announcing that the Food and Drug Administration has created two new Affirmation of Compliance (AofC) codes - KIT and DDM - to address shipments of kits containing finished devices imported into the U.S.
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KIT Should Be Used to Identify Individual Devices within Kits
In order to clearly identify that the finished devices are part of a kit, a new AofC code KIT, Imported Kit of Finished Devices, has been developed. The code KIT should be used for all individual devices within kits imported in the U.S. There is no associated qualifier.
DDM Should Be Used to Identify Domestic Manufacturers of Devices in Kits
Additionally, the new AofC code DDM, Domestic Device Manufacturer, will be used to facilitate identification of the manufacturer of any individual device within the kit that was manufactured in the U.S. (American Goods Returned). DDM is only to be used for those U.S. manufactured devices declared as part of a kit. The code and qualifier should be the device registration number issued by FDA’s Center for Devices and Radiological Health (CDRH) for the U.S. firm manufacturing the product identified in the FDA line.
DEV/DFE Should Continue to Be Used for Foreign Manufacturers or Exporters
DEV/DFE should continue to be used for the foreign manufacturers or exporters of individual finished devices within the kits.
Use of Codes Will Help Expedite Entry Review Process
Use of these codes affirms that the product identified in a FDA line meets the requirements specific to the code. While use of the codes is voluntary, transmission will help expedite the entry review process.
Some Kits with Drug Products Must Comply with Labeling & Approval Reqs
Additionally, some kits contain drug products which must comply with applicable labeling and approval requirements including, but not limited to, application number, registration, and listing. For example, the foreign firm's drug registration per the Food, Drug, and Cosmetic (FD&C) Act section 510(i) must include the known U.S. importers. If the registration does not include the importer or consignee, then detention may be indicated.
Kit importers should consider obtaining the AofC information from their vendors to minimize the need for manual review of applicable lines by the FDA.
(Note that the information in this transmission only applies to medical device kit importers who have been specifically informed by CBP that they must transmit every device contained in a kit on a separate line (also referred to as "X" and "V" lines). Importers of medical device kits who transmit only the kit as a single line should continue to use the AofC codes DEV (foreign manufacturer medical device registration #) and LST (medical device listing #) applicable for the medical device kit.)
(CSMS #11-000315)